Pain Therapeutics Announces FDA Has Cleared an Investigational New Drug (IND) Application for PTI-125
July 31 2017 - 8:00AM
Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company,
is pleased to announce that the U.S. Food and Drug Administration
(FDA) has cleared its Investigational New Drug (IND) application
for PTI-125, a novel drug candidate to treat Alzheimer’s Disease.
As a result, clinical testing with PTI-125 will begin shortly, with
funding provided by a $1.7 million research grant from the National
Institutes of Health (NIH).
PTI-125 will initially be tested in a Phase I
‘first-in-human’ study to observe measures of safety and
pharmacokinetics and to inform dosing for future studies. The
design of this Phase I study was based on FDA feedback, clinical
and scientific rationale and observations from previously conducted
preclinical and in vitro studies. Study results are expected by
year-end 2017.The Company’s Phase I study with PTI-125 will be
funded by a $1.7 million grant from the NIH. The NIH's National
Institute on Aging awarded this research grant to Pain Therapeutics
following a competitive, peer-reviewed evaluation of PTI-125 on
scientific merit and clinical promise by a panel of academic,
clinical and industry experts in Alzheimer's Disease and other
neurological disorders. The underlying science for PTI-125 has been
published in Journal of Neuroscience, Neurobiology of Aging,
Journal of Biological Chemistry, PLOS-One and other peer-reviewed
scientific journals.
About Alzheimer's Disease and PTI-125
Alzheimer's Disease (AD) is a progressive brain
disorder that slowly destroys memory and thinking skills, and
eventually the ability to carry out the simplest tasks. There is no
approved drug therapy to reverse, or even halt, the course of AD.
PTI-125 is an oral, small molecule drug candidate that was designed
in-house and characterized by outside collaborators. PTI-125 has
been shown to significantly improve AD neuropathologies in mouse
models of the disease and in post-mortem brain tissue from AD
patients, including receptor dysfunctions, neuroinflammation, tau
hyperphosphorylation, insulin resistance and plaques and tangles
that are hallmarks of AD.
Pain Therapeutics owns worldwide commercial
rights to PTI-125 and related technology.
About Pain Therapeutics,
Inc.
Pain Therapeutics, Inc. is a clinical-stage
biopharmaceutical company that develops novel drugs. The FDA has
not yet established the safety or efficacy of any of our drug
candidates. For more information, please visit
www.paintrials.com.
Note Regarding Forward-Looking
Statements: This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Pain Therapeutics disclaims any intent or
obligation to update these forward-looking statements, and claims
the protection of the Safe Harbor for forward-looking statements
contained in the Act. Examples of such statements include, but are
not limited to, statements regarding the safety or effectiveness of
PTI-125 and the Company's plan to initiate a clinical study with
PTI-125. Such statements are based on management's current
expectations, but actual results may differ materially due to
various factors. Such statements involve risks and uncertainties,
including, but not limited to, those risks and uncertainties
relating to our ability to predict the actual effects of PTI-125 on
people before it is studied in humans; our ability to demonstrate
the safety, efficacy or potential health benefits of PTI-125 in
humans; unexpected adverse side effect; and our ability to
determine which patient, or subpopulation of patients, may benefit
from treatment. For further information regarding these and other
risks related to our business, investors should consult our filings
with the U.S. Securities and Exchange Commission.
For More Information Contact:
Ruth Araya
Pain Therapeutics, Inc.
IR@paintrials.com
(512) 501-2485
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